NCT05303155

Brief Summary

Although COVID-19 infects gastrointestinal tissues, little is known about the roles of gut commensal microbes in susceptibility to and severity of infection. The investigators will analyze the alterations in fecal microbiomes of patients with COVID-19 infection during hospitalization.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

March 18, 2022

Last Update Submit

May 18, 2023

Conditions

Coronavirus InfectionsGut MicrobiomeChildhood ALL

Outcome Measures

Primary Outcomes (1)

  • The analysis of fecal microbiome of patient with COVID 19

    The analysis of fecal microbiome of patient with COVID 19, using 16S rRNA sequencing

    through study completion, an average of 1 year

Study Arms (2)

Patient with COVID 19

Pediatric patient infected by COVID 19

Diagnostic Test: 16S rRNA sequencing

Pediatric patient without infection of COVID 19

Pediatric patient without infection of COVID 19

Diagnostic Test: 16S rRNA sequencing

Interventions

16S rRNA sequencingDIAGNOSTIC_TEST

Fecal microbiome analysis using 16S rRNA sequencing

Patient with COVID 19Pediatric patient without infection of COVID 19

Eligibility Criteria

Age3 Months - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Those who were hospitalized because of the COVID 19 were enrolled.

You may qualify if:

  • patients infected with COVID 19

You may not qualify if:

  • congenital heart, renal, intestinal disease
  • malignancy
  • immunologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07440, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal microbiome

MeSH Terms

Conditions

Coronavirus InfectionsPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • KY YOUNG CHO, MD, PhD

    Hallym University Kangnam Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KY YOUNG CHO, MD, PhD

CONTACT

821090910197choky96@naver.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 31, 2022

Study Start

April 14, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

KR(1)